Traditionally, tracheostomy tubes were customarily supported in place by a thin cotton tape extending around the neck of a patient, and the ends of the tape were tied to openings in the flanges of a flanged neck plate of the tracheostomy tube in a variety of ways. One method of securing the cotton tape to two openings in the flanges of the neck plate is to cut a small opening lengthwise in the cotton tape in one end, then thread the other end of the cotton tape through one of the two openings in the flange of the neck plate and bring it through the opening cut in the cotton tape on the other end and pull it through, thereby securing one end of the cotton tape to the opening in the flange of the neck plate. The free end of the cotton tape is then brought behind and around the neck of a patient and threaded through the opening in the flange of the neck plate on the opposite side. The cotton tape is then pulled back and tied in a knot to itself to secure the tracheostomy tube to the patient.
Other methods of securing the tracheostomy tube to a patient using the cotton tape include using the same method as described above to attach the cotton tapes to the openings in the flanges of the neck plate after having first cut the cotton tape in two pieces, of different lengths, then bringing the longer piece of the cotton tape behind and around the neck of a patient and tying it in a knot to the other end of the shorter cotton tape on the opposite side of the neck.
Knots may be tied directly to openings in the flanges of the neck plate with the longer piece of cotton tape again being secured to the shorter end in the manner previously described.
The cotton tape may be threaded through the openings in the flanges of the neck plate as one piece with the ends of the tapes being knotted together to one side of the neck of a patient with an intermediate length of the tape extending horizontally directly over or under the tracheostomy tube which is centered in the neck plate, or the knot may be tied with the two free ends of the cotton tape brought up from below the openings in the flanges of the neck plate and threaded through with the ends tied in a knot either directly above or below the tracheostomy tube.
The cotton tape, which is very light and flimsy, has a tendency to curl and roll, forming a rope-like strap. This can be uncomfortable to a patient and may cause irritation to the skin from chafing.
The methods of securing the cotton tape to the openings in the flanges of the neck plate of a tracheostomy tube device to the neck of a patient may cause injury to the soft tissues surrounding the tracheostomy. This injury factory is the result of the tracheostomy tube device deviating from the midline of the trachea within the neck of a patient toward the side of the neck where the ends of the cotton tape are tied together. Pressure is exerted on the soft tissues until the tape is readjusted to displace the tracheostomy tube device from engaging the stoma wall.
When the cotton tape ends are tied in a knot directly over or beneath the tracheostomy tube which is centered in the neck plate of the tracheostomy tube device, pressure is exerted directly over the stoma of the tracheostomy.
These traditional methods of securing the cotton tape to the tracheostomy tube device to the neck of a patient contribute to the potential for injury of the soft tissues surrounding the stoma of a tracheostomy.
When the tracheostomy tube device is not maintained in the midline position within the trachea of the neck of a patient, the soft tissues surrounding the original incision forming the tracheostomy may erode from the constant pressure being exerted on the walls of the stoma, thus enlarging the opening of the stoma.
Infection and the loss of a good air seal may result in a patient with a damaged tracheostomy stoma. Considerable pain and discomfort may be experienced by a patient with a damaged tracheostomy stoma.
Cotton tapes may be secured too tightly around the neck of a patient, causing pain and a discomfort as well as possibly impeding the return of blood flow from the head and neck of a patient.
Cotton tapes may be secured too loosely, the knots may loosen or become untied causing the inadvertent loss of the airway or displacement of the tracheostomy tube device into the subcutaneous tissues of a patient's neck and/or chest areas causing further complications to a patient.
U.S. Pat. No. 4,569,248 to Hasslinger, issued Feb. 11, 1986, reports that the separable fasteners such as those described in U.S. Pat. Nos. 2,7171,437 and 3,009,235 which are marketed under the registered trademark VELCRO brand hook and loop fasteners by Velcro USA, Inc., 521 Fifth Avenue, New York, N.Y. have gained wide acceptance because of the properties of the mating hooks and loops. A surface defined by the hooks exposed on an outer surface of one flexible tape is merely placed into face-to-face relationship with a surface defined by the loops exposed on an outer surface of an overlapping tape so that a large number of hooks engage a large number of loops and therefore are able to resist separation of the tapes by forces parallel to the interfacial plane of engagement but are readily separable by peeling forces applied substantially normal to this interfacial plane. These fastening devices are generally formed of a sheet of synthetic woven or knitted fabric having raised threads of synthetic material, such as nylon, which are napped or unnapped to provide a pile surface defined by a plurality of loops, and which may be thermally treated to become semi-rigid. Certain of the loops may then be cut along one side near their outer extremity to form hooks.
These fasteners have been used in numerous applications, particularly because of their unique touch and close fastener capability as well as their fastening strength. The unique fastening capability of these hook and loop type engaging elements have been applied to particular use to create various fastener arrangements.
In particular, fasteners of this type are used either along or as major components of strapping devices of various types. The applications of these separable hook and loop type fasteners have reduced the need for traditional strap fastening devices such as buckles. Also, to the extent that earlier fastening devices did not generally facilitate variable and precise fastening, these separable fasteners have provided substantial advantages.
The advent of VELCRO fastening means made it possible to adjust the length of the VELCRO fastening means to conform more closely to the length of the circumference of the neck about which the VELCRO fastening means is fastened. However, VELCRO fastening means are not as permanent.
These VELCRO fastening means have the characteristics of being designed in a straight line with the VELCRO fastening means in the form of tapes extending from the back of these one or two piece bands. When these VELCRO tapes are applied to the neck of a patient, the VELCRO tracheostomy tapes that are threaded through the openings in the flanges of the neck plate tend to rest against the top of the openings in the flanges of the neck plate causing a firm, upward pressure on the stoma of the tracheostomy.
The materials used in the manufacture of the various types of VELCRO fastening means tend to stretch and lose their basic shape and strength with repeated use and washings The fabric used in these VELCRO fastening means may weaken, with the tracheostomy tapes of these VELCRO fastening means potentially loosening and slipping out of the openings in the flanges of the neck plate. The loss of a patient's airway may result with the failure of the VELCRO fastening means to remain securely fastened. The elastic band of the VELCRO fastening means loses its elasticity with repeated use.
The addition of ventilator tubing and indwelling suction equipment on a patient who requires mechanical assistance with breathing and removal of pulmonary secretions causes additional stress to be placed on the VELCRO fastening means for securing and maintaining a tracheostomy tube properly within the neck of a patient.
In addition, prior art devices that include the traditional cotton tape and the Velcro-type bands for supporting a tracheostomy tube are exposed to mucous, blood, sweat, wound drainage from the tracheostomy stoma or from draining surgical wounds on the head or neck of a patient. Exposure of the cotton tapes or bands of VELCRO fastening means to the aforementioned contaminants requires that the cotton tape be changed, or the VELCRO fastening means removed and washed, replaced in the meantime with a fresh VELCRO fastening means. Failure to change soiled tracheostomy tapes of the cotton tape type or the VELCRO fastening means may result in skin irritation and/or wound infection in a patient who has prolonged exposure to the previously described secretions.